Navigating the Tricky Medical Technology Landscape

August 30, 2017

7:15 am

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The wearable and personal health industry has grown over the past few years. After all, the App and Play stores have more than 165,000 health apps available and the technology is getting far more advanced. However, while tech entrepreneurs are pumping out new apps and wearables at a record pace, many lack the knowledge of market access and scalability within the healthcare industry.

In the traditional medical technology sector, successful incumbents tend to have a conservative mentality forced by a system that ensures clinical-grade worthiness. Compare that to the mindset of the typical Silicon Valley tech entrepreneur who moves fast and breaks things to innovate their industry, and you end up with what ultimately led to the Theranos disaster.

Cutting Corners Won’t Lead to Long-Term Success

Too often, founders of medical startups cut corners with no intention to take a clinical-grade approach. It’s an effective way to rapidly test interest, but it’s unlikely to crack a venture capital-worthy opportunity. To truly improve a patient’s status, apps and wearables must drive behavioral change by addressing the most crucial issues within the healthcare industry.

Spry Health is a great example, with its validation study that convinced leading healthcare organizations of parity effectiveness with other standards of care. Pharmaphorum reports that Spry’s wearable Loop is a clinically reliable measure for blood pressure, heart rate, oxygen saturation, respiration, and CO2 monitoring, which led to a $5.5 million investment.

If you want to emulate that success, you’ll need a clinically robust product that can pass these three strategic imperatives for market access:

Focus on Clinical Accuracy

Wearables have the potential to transform healthcare, but only if they’re accurate. Even some of the most popular wearable technology — including the Apple Watch, Fitbit Surge, and Samsung Gear S2 — were found to be inaccurate in some areas.

Before they can begin marketing, companies need a strategy to define and prioritize clinical indications for use, positioning versus alternatives, and sufficient clinical evidence.

Build Financial Infrastructure

Even a product that can change the world is useless if nobody buys it. A surefire strategy lays out patient population prevalence and incidence; the flow of revenue and costs through the related healthcare delivery value systems; the clinical and economic arguments to gain doctor, hospital, and payer buy-in; and the right locations to get it in front of patients.

Entrepreneurs often assume patients will pay out of pocket. Most won’t. Partnering with a major player — like Rock Health Ventures does with partners Blue Shield of California and CVS Health — is a great way for startups to scale the barriers to market.

Consider Hospital Capacity

Efficacy and economic factors aside, founders should know what it takes for physicians and hospitals to offer wearables as a part of a therapy package. Health system resources and capabilities are strained and exhausted already, and new clinical solutions take dedicated professionals to promote, resources to support, and sometimes even physical space, so it’s important to understand the human and on-site barriers that may prevent usage.

Will it be prescribed by physicians or provided by nurses? How will the user experience integrate with and reduce hospital workload obligations? What can be bypassed or automated? These issues should be discussed — if not resolved — upfront.

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Sandy Hathaway is a founding partner of Exit3x, and also co-founded technology startups RetentionGrid, which focuses on big data and predictive analytics, and AVARI, involving machine learning and personalization. For the last 20 years, Sandy has worked in strategy, business innovation, go-to-market, and growth roles in the medical device industry, including with U.S. market leader Medtronic and German remote monitoring pioneer BIOTRONIK, and she specializes in working with companies in heavily regulated and deep tech industries.